Duloxetine may improve stress incontinence: drug under FDA review.(Gynecology)

HOLLYWOOD, FLA. -- Significantly more women with urodynamic stress incontinence reported improvement and reconsidered surgery after 8 weeks of duloxetine treatment, compared with those taking a placebo, in a study of 109 women.

This is the first study to evaluate duloxetine for severe urodynamic stress incontinence, defined as at least 14 episodes of incontinence per week, Dr. Linda Cardozo said at the annual meeting of the American Urogynecologic Society.

Duloxetine is currently under Food and Drug Administration review; approval is expected in late 2004 or early 2005, according to Eli Lilly & Co.

Investigators assessed 109 women from 14 centers in Australia, Canada, the Netherlands, and the United Kingdom--countries where women typically wait for surgery. Participants were randomly assigned to receive placebo (54) or duloxetine at 40 mg twice a day for 4 weeks, followed by 60 mg twice a day for another 4 weeks (55 women). Outcome measures included changes in incontinence episode frequency, number of continence pads used, and patient assessments using the Incontinence Quality of Life (I-QOL) questionnaire, Patient Global Impression of Improvement (PGI-I) and Severity (PGI-S) ratings, and Willingness to Consider Surgery (WCS).

The subjects' mean age was 53 and mean BMI was 28; 94% were white. The two groups were well matched demographically, said Dr. Cardozo, professor of urogynecology at King's College Hospital, London, ...